Story highlights

Generic drugs account for an estimated 80 percent of all prescriptions

Drug company says it cannot comply with both federal and state demands

Karen Bartlett walked gingerly down the marble steps of the Supreme Court on Tuesday, guided on the arms of her lawyer. She is legally blind, the result of a serious reaction to a generic drug.

Her medical condition was debated before the justices, testing whether federal law prevents her multi-million-dollar "design-defect" judgment against the pharmaceutical company from standing up in state court.

A cautious bench revealed little about how it will rule in this closely watched case.

Generic drugs account for an estimated 80 percent of all prescriptions and patient-rights advocates say companies should be held accountable for unsafe, poorly made products regardless of whether they are brand name or generic.

Photos: Supreme Court cases that changed America 17 photos

Photos: Supreme Court cases that changed America17 photos

Supreme Court cases that changed America – Hollingsworth v. Perry (2013): The Supreme Court dismissed an appeal over California's Proposition 8 on jurisdictional grounds. The voter-approved ballot measure barring same-sex marriage was not defended by state officials, but rather a private party. This ruling cleared the way for same-sex marriage in California to resume, but left open-ended the legal language of 35 other states barring same-sex marriage. Take a look at other important cases decided by the high court.

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Supreme Court cases that changed America – United States v. Windsor (2013): When her wife died in 2009, Edith Windsor, 84, was forced to pay hundreds of thousands of dollars in estate taxes because her marriage was not recognized by the federal government's Defense of Marriage Act of 1996. The Supreme Court struck down the part of the law which denied legally marriage same-sex couples the same federal benefits provided to heterosexual spouses.

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Supreme Court cases that changed America – National Federation of Independent Business v. Sebelius (2012): The Supreme Court upheld most of the Affordable Care Act, the Obama administration's health care reform law, on June 28, 2012. The decision determined how hundreds of millions of Americans will receive health care.

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Supreme Court cases that changed America – Citizens United v. Federal Election Commission (2010): Activists rally in February 2012 to urge the Supreme Court to overturn its decision that fundamentally changed campaign finance law by allowing corporations and unions to contribute unlimited funds to political action committees not affiliated with a candidate.

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Photos: Supreme Court cases that changed America17 photos

Supreme Court cases that changed America – Texas v. Johnson (1989): The Supreme Court overturned the decision that convicted Gregory Lee Johnson of desecrating a venerated object after he set an American flag on fire during a protest. The court ruled that Johnson (at right with his lawyer, William Kunstler) was protected under the First Amendment right to freedom of speech.

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Supreme Court cases that changed America – United States v. Nixon (1974): When President Richard Nixon claimed executive privilege over taped conversations regarding the Watergate scandal, the Supreme Court ruled that he had to turn over the tapes and other documents. The ruling set a precedent limiting the power of the president of the United States.

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Supreme Court cases that changed America – Roe v. Wade (1973): Norma McCorvey, identified as "Jane Roe," sued Dallas County District Attorney Henry Wade over a law that made it a felony to have an abortion unless the life of the mother was in danger. The court agreed with Roe and overruled any laws that made abortion illegal in the first trimester. Here, McCorvey, left, stands with her attorney Gloria Allred in 1989.

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Supreme Court cases that changed America – Miranda v. Arizona (1966): Ernesto Miranda confessed to a crime without the police informing him of his right to an attorney or right against self-incrimination. His attorney argued in court that the confession should have been inadmissible, and in 1966, the Supreme Court agreed. The term "Miranda rights" has been used since.

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Supreme Court cases that changed America – Gideon v. Wainwright (1963): The Supreme Court overturned the burglary conviction of Clarence Earl Gideon after he wrote to the court from his prison cell, explaining he was denied the right to an attorney at his 1961 trial.

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Supreme Court cases that changed America – Mapp v. Ohio (1961): The Supreme Court overturned the conviction of Dollree Mapp because the evidence collected against her was obtained during an illegal search. The ruling re-evaluated the Fourth Amendment, which protects citizens against unreasonable searches and seizures.

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Supreme Court cases that changed America – Brown v. Board of Education (1954): Nathaniel Steward recites his lesson surrounded by white classmates at the Saint-Dominique School in Washington. In Brown v. Board of Education, the Supreme Court ruled that it was unconstitutional to separate students based on race.

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Supreme Court cases that changed America – Korematsu v. United States (1944): Fred Korematsu, a Japanese-American man, was arrested after authorities found out that he claimed to be a Mexican-American to avoid an internment camp during World War II. The court ruled that the rights of an individual were not as important as the need to protect the country during wartime. In 1998, President Bill Clinton awarded Korematsu the Presidential Medal of Freedom.

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Supreme Court cases that changed America – Plessy v. Ferguson (1896): Homer Plessy was arrested when he refused to leave a whites-only segregated train car, claiming he was 7/8 white and only 1/8 black. The Supreme Court ruled that "separate but equal" facilities for blacks were constitutional, which remained the rule until Brown v. Board of Education in 1954.

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Supreme Court cases that changed America – Dred Scott v. Sandford (1857): When Dred Scott asked a circuit court to reward him his freedom after moving to a free state, the Supreme Court ruled that Congress didn't have the right to prohibit slavery and, further, that those of African-American descent were not protected by the Constitution.

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Supreme Court cases that changed America – Gibbons v. Ogden (1824): This was the first case to establish Congress' power to regulate interstate commerce. The ruling signaled a shift in power from the states to the federal government. Aaron Ogden, seen here, was given exclusive permission from the state of New York to navigate the waters between New York and certain New Jersey ports. When Ogden brought a lawsuit against Thomas Gibbons for operating steamships in his waters, the Supreme Court sided with Gibbons.

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Supreme Court cases that changed America – McCulloch v. Maryland (1819): In response to the federal government's controversial decision to institute a national bank in the state, Maryland tried to tax the bank out of business. When a federal bank cashier, James W. McCulloch, refused to pay the taxes, the state of Maryland filed charges against him. In McCulloch v. Maryland, the Supreme Court ruled that chartering a bank was an implied power of the Constitution. The first national bank, pictured, was created by Congress in 1791 in Philadelphia.

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Supreme Court cases that changed America – Marbury v. Madison (1803): When Secretary of State James Madison, seen here, tried to stop Federal loyalists from being appointed to judicial positions, he was sued by William Marbury. Marbury was one of former President John Adams' appointees, and the court decided that although he had a right to the position, the court couldn't enforce his appointment. The case defined the boundaries of the executive and judicial branches of government.

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Today's Supreme Court 10 photos

Today's Supreme Court10 photos

The justices of the U.S. Supreme Court sit for their official photograph on October 8, 2010, at the Supreme Court. Front row, from left: Clarence Thomas, Antonin Scalia, Chief Justice John G. Roberts, Anthony M. Kennedy and Ruth Bader Ginsburg. Back row, from left: Sonia Sotomayor, Stephen Breyer, Samuel Alito Jr. and Elena Kagan.

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John G. Roberts – In 2005, Chief Justice John G. Roberts was nominated by President George W. Bush to succeed Justice Sandra Day O'Connor as an associate justice. After Chief Justice William Rehnquist died, however, Bush named Roberts to the chief justice post. The court has moved to the right during his tenure, although Roberts supplied the key vote to uphold President Barack Obama's Affordable Care Act.

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Antonin Scalia – Justice Antonin Scalia was appointed by President Ronald Reagan in 1986 to fill the seat vacated by Justice William Rehnquist when he was elevated to chief justice. A constitutional originalist -- and a colorful orator -- Scalia is a member of the court's conservative wing. He is currently the court's longest-serving justice.

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Anthony M. Kennedy – Justice Anthony M. Kennedy was appointed to the court by President Ronald Reagan in 1988. He is a conservative justice but has provided crucial swing votes in many cases, writing the majority opinion, for example, in Lawrence v. Texas, which struck down that state's sodomy law.

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Clarence Thomas – Justice Clarence Thomas is the second African-American to serve on the court, succeeding Justice Thurgood Marshall when he was appointed by President George H. W. Bush in 1991. He is a conservative, a strict constructionist who supports states' rights.

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Ruth Bader Ginsburg – Justice Ruth Bader Ginsburg is the second woman to serve on the Supreme Court. Appointed by President Bill Clinton in 1993, she is a strong voice in the court's liberal minority.

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Stephen G. Breyer – Justice Stephen G. Breyer was appointed to the court in 1994 by President Bill Clinton. He is considered a member of the court's liberal minority.

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Samuel A. Alito Jr. – Justice Samuel A. Alito Jr. was appointed by President George W. Bush in 2006 and is known as one of the most conservative justices to serve on the court in modern times.

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Sonia Sotomayor – Justice Sonia Sotomayor is the court's first Hispanic and third female justice. She was appointed by President Barack Obama in 2009 and is regarded as a resolutely liberal member of the court.

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Elena Kagan – Justice Elena Kagan is the fourth female justice and a member of the court's liberal wing. She was appointed in 2010, at the age of 50, by President Barack Obama and is the court's youngest member.

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That number is expected to rise in coming years with patent protection due to expire on several popular and lucrative consumer drugs, including Lipitor and Viagra.

The blockbuster health care reform bill championed by President Barack Obama would also encourage greater use of generics. About a third of generic drugs have no brand name competitors.

But Mutual Pharmaceutical counters it received Food and Drug Administration approval and that it cannot comply with both federal and state standards of care when it comes to drug safety and marketing.

The state jury "didn't say that 'yes, you can market this drug, it benefits 99.9 percent of the people, but there is that 0.1 percent, and you're going to have to compensate that person," said Chief Justice John Roberts. "They said the risks outweigh the benefits, period. So you should not market this at all. And that does seem inconsistent with the federal regime."

She was placed in a medically-induced coma for 100 days and suffered lung and esophageal damage.

Nine years and 12 surgeries later, Bartlett looked weak and needed help standing on the high court plaza after arguments.

A state court jury awarded her more than $21 million in compensatory damages, finding the generic was "unreasonably dangerous." Mutual eventually took its case to the high court.

This appeal is the latest the Supreme Court justices have wrestled with in recent years over liability from defective drugs. Most have turned on the tricky legal line between state and federal discretion.

Generic drug makers are trying to dismiss these kinds of design-defect lawsuits. They cite a 1984 congressional law pre-empting state "failure-to-warn" claims.

Drug companies have long asserted various doctrines of pre-emption, saying they are protected from most product-liability claims if they have met federal safety approval standards.

They argue that federal regulatory judgments trump state consumer safety laws, which are often tougher than Washington's standards.

But the high court had given a big victory to patients and consumer rights groups in 2009 when it ruled in favor of plaintiff who sued Wyeth -- now owned by Pfizer -- after losing an arm to gangrene from a common, brand-name anti-nausea prescription medication. She had won a $7 million judgment from a Vermont jury for her claims.

Then last year, the Supreme Court ruled 5-4 that generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.

The conservative majority noted that Congress, not the courts, could change the law if they wanted.

Bartlett's case goes beyond the so-called "failure to warn" standard and applies to the safety of the drug itself.

A federal appeals court in Boston ruled for Bartlett, calling her situation "disastrous." It concluded Mutual could have simply taken the drug off the market following scattered reports of dangerous side-effects.

The Obama administration backed the drug company, concerned that if state lawsuits are not pre-empted by federal law, that would reduce the incentive for generic drug makers to provide the most current safety information to the FDA, and affect patient care.

That sentient was echoed by lawyers representing the Philadelphia-based company.

"This is a situation where we had a $21-million-dollar verdict with respect to a drug that hundreds of thousands of people were taking at the time, and while it's true that about one out of a million had a terrible, terrible adverse reaction, hundreds of thousands are benefiting from the drug," Jay Lefkowitz told CNN after the argument.

"The drug was only selling about $6-7 million a year in gross sales. If you have more verdicts like this, they are going to take drugs off the market," he said.

The company also says it should be protected from such lawsuits because by law they are not allowed to change the product or its label.

But David Frederick, Bartlett's attorney, slammed the Obama administration's position that its regulatory judgment supersedes state courts "second-guessing" its expert, science-based authority.

"The federal government took a sweeping and unprecedented position today where it had taken no regulatory action and nonetheless asserted because it had information in its files, that that displaced state law," said Frederick. "I've been arguing cases in this court for a long time. I've never heard such a broad assertion of federal power."

A second separate case over generic drugs will be argued next week at the Supreme Court, dealing with so-called "reverse payment" agreements between competing generic and brand-name manufacturers.

As for Bartlett, she attended the morning arguments, but was reluctant to predict an outcome.

"I want generic drug makers to be held accountable for the harm they did to me and others," she told CNN. "The same as brand-name drugs."

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